Tobacco Use DisorderNCT03551704
Smoking Cessation Treatment for Substance Use Dependents
A study testing CBT + EFT and CBT + EFT + CM in people with Tobacco Use Disorder, run by University of Oviedo at 1 site in Spain.
Trial summary
The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with substance use disorders (SUDs). For this purpose, two smoking cessation treatments tailored for SUDs will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- CBT + EFT and CBT + EFT + CM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2018to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being aged 18 or over.
- Having smoked 10 or more cigarettes/day within the last year.
- Meeting the diagnostic criteria for nicotine dependence according to the Diagnostic and Statistical Manual of Mental Disorders-5th ed. (American Psychiatric Association 2013).
- Undergoing outpatient cocaine or alcohol treatment.
Who cannot join
- Not being able to attend the entire treatment.
- Being currently receiving other psychological/pharmacological treatment for smoking cessation.
- Being diagnosed with a current severe psychiatric disorder (i.e., schizophrenia,bipolar disorder).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical Unit of Addictive Behaviors
Oviedo, Principality of Asturias, 33003
About this study
The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with substance use disorders (SUDs). For this purpose, two smoking cessation treatments tailored for SUDs will be assessed. Participants will be assigned to one of the following treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation (CBT) + Episodic Future Thinking (EFT); 2) The same treatment alongside Contingency Management (CM) for shaping abstinence.
The main goals are:
- To analyze the feasibility (e.g., acceptability, compliance) of implementing the abovementioned protocol treatments to a community setting.
- To assess abstinence rates in each treatment condition at short and long-term follow-ups: post-treatment, one, two, three, six and twelve months after post-treatment.
- To assess the effects of smoking abstinence on other substance use.
- To analyze the moderating effect of individual variables over treatment outcomes: sociodemographic characteristics, drug demand, severity of nicotine dependence and SUD, severity of depressive symptomatology and impulsivity.
Read the detailed description
Cigarette smoking continues to have a startling adverse impact on public health, leading to more than 5 million premature deaths annually worldwide. Smoking rates are disproportionately high among the population suffering from substance use disorders (SUDs) (e.g., alcohol or cocaine). In this regard, smokers with comorbid SUD are more likely to smoke heavily and meet criteria for high nicotine dependence. As they experience more difficulty in quitting smoking than their non-SUDs counterparts, they present lower rates of abstinence.
In recent years there has been a great interest in developing effective strategies to promote abstinence in smokers with SUDs. In particular, a proliferation on CM treatments for smokers with SUDs has been recently produced. There is promising evidence for the positive effect of CM treatments upon both quitting smoking and both legal and illegal abuse drugs. On the other hand, CM has shown promising results in promoting both retention and nicotine abstinence among comorbid and non-comorbid smokers. Nevertheless, there is a lack of research exploring the effectiveness of CM on smokers with SUDs.
The primary aim of this clinical trial is to yield data on the effectiveness of CM for smoking cessation in smokers with SUDs. To address this issue, both CBT for smoking cessation plus EFT, and the same treatment alongside CM for shaping abstinence will be assessed. Participants will be randomly assigned to one of the following treatment conditions: 1) CBT+EFT; 2) CBT+EFT+ CM.
In view to assure adequate power for achieving statistical significance, investigators carried out a priori power analysis by using the G*Power 3.1. An estimated sample size of 120 participants would detect a medium effect size (Cohen's d = 0.3, with power (1-β) set at 0.97 and α = 05).
The primary analyses derived from this clinical trial will be conducted using Statistical Package for the Social Science (SPSS) version 24 for Windows. A set of descriptive and frequency analyses will be carried out with regard to participants' characteristics. Comparisons between treatment groups in both baseline characteristics and treatment outcomes will be conducted using a set of chi-square tests for categorical variables and t-tests (two-tailed) for continuous variables.
- Conditions
- Tobacco Use Disorder
- Being tested
- CBT + EFT, CBT + EFT + CM
- Keywords
- Smoking, Substance addiction, Cocaine, Alcohol, Behavioral treatment
- Medical subject headings
- Tobacco Use Disorder, Smoking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT + EFTBehavioural
The CBT treatment will be implemented in 8-week group-based sessions (maximum 4 patients). Sessions will be carried out once a week over an 8-week period, with quit date occurring at fifth session. Patients will be asked to gradually reduce their nicotine intake (i.e., 25% each week). CBT components include: psychoeducation, self-monitoring, physiological feedback, training in stimulus control and strategies for controlling negative discomfort, and relapse prevention strategies.
As part of the EFT, participants will be asked to select future smoking-related events that would occur within the following time periods: 2 weeks, 1, and 6 months. They will be instructed to generate personal audio recordings that will be used to help them think about future decision-making choices.
CBT + EFT + CMBehavioural
This intervention includes the abovementioned treatment components and a CM procedure reinforcing abstinence. This arm will consist on delivering CBT and EFT and providing patients incentives to promote and reinforce abstinence contingent on abstinence. The schedule will incorporate an increasing magnitude of reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| CBT + EFT | Active comparator | The CBT treatment will be implemented in 8-week group-based sessions (maximum 4 patients). Sessions will be carried out once a week over an 8-week period, with quit date occurring at fifth session. Patients will be asked to gradually reduce their nicotine intake (i.e., 25% each week). CBT components include: psychoeducation, self-monitoring, physiological feedback, training in stimulus control and strategies for controlling negative discomfort, and relapse prevention strategies.
As part of the EFT, participants will be asked to select future smoking-related events that would occur within the following time periods: 2 weeks, 1, and 6 months. They will be instructed to generate personal audio recordings that will be used to help them think about future decision-making choices. Receives: Behavioral: CBT + EFT |
| CBT + EFT + CM | Experimental | This intervention includes the abovementioned treatment components and a CM procedure reinforcing abstinence. This arm will consist on delivering CBT and EFT and providing patients incentives to promote and reinforce abstinence contingent on biochemical verification. The schedule will incorporate an increasing magnitude of reinforcement. Receives: Behavioral: CBT + EFT + CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Smoking Abstinence
Abstinence is defined as achieving a period of at least 24 hours of abstinence (end-of-treatment) or not smoking since the prior last 7 days. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
Measured: End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up
Changes in Continuous abstinence
Abstinence is defined as no smoking (not even a puff) since the participant´s quit day. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
Measured: 1, 2, 3, 6 and 12 month follow-up since the treatment completion
Secondary outcomes (6)
Changes in Other Substance Abstinence
7-day point-prevalence. Self-reported abstinence will be confirmed by urinalyses and breath alcohol samples.
Measured: End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up since the treatment completion
Changes in Drug demand
Alcohol and tobacco demand will be assessed by using the Alcohol and Tobacco Purchase Task. These tasks allow to capture changes in the relative reinforcing efficacy of different drugs through the course of treatment. From this tasks, five demand indices are derived. Specifically, we will compute the indices that follow:
Breakpoint: The first price at which consumption is zero
Omax: maximum expenditure for cigarettes
Pmax: price at which expenditure is maximized
Intensity: consumption at the lowest price
Elasticity: sensitivity of cigarette consumption to increases in costs
Measured: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Changes in Health-Related Quality of Life
This variable will be assessed by using the EuroQol-5D (EQ-5D). It essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.
Measured: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Changes in Depression
Depression will be assessed using the Beck's Depression Inventory- Second Edition (BDI-II). Scores are examined as a continuous scale. None/minimal depression is defined as scoring below the clinical screening BDI cutoff of mild depression (<14). Depression diagnosis is assessed in those individuals scoring 14 or more on the BDI-II by means of the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-Clinical Version (SCID-I/CV).
Measured: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Changes in Impulsivity
Impulsivity levels will be assessed by means of the delay discounting task. Participants will complete a computerized version of this task and will be presented with several choices. An adjusting-amount procedure will be used (Holt, Green, \& Myerson, 2012). The delay values used are one day, one week, one month, six months, one year, five years, and 25 years. Delay discounting is calculated using logk and the area under the curve (AUC).
Measured: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Cost Analysis
The Drug Abuse Treatment Cost Analysis Program (DATCAP) is a cost data collection instrument and interview guide designed to be used in a variety of medical treatment and social service settings.
The instrument is intended to collect and organize detailed information on resources used in service delivery and their associated dollar cost. Resource categories include personnel, supplies and materials, contracted services, buildings and facilities, equipment, and miscellaneous items.
The Drug Abuse Treatment Cost Analysis Program (DATCAP) is a cost data collection instrument and interview guide designed to be used in a variety of medical treatment and social service settings.
Measured: End of the project when all participant´s data are collected. Data expected: three years after the study onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start15 Jan 2018
- Primary completion30 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to each of the two treatment conditions in accordance with a computer-generated randomization list. The treatment conditions will be actively running in parallel.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Secades-Villa, PhD, University of Oviedo
- Investigators
- Roberto Secades-Villa, PhD, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551704
- Sponsor's protocol ID
- MSSSI-2017-2017I036
- Status last verified
- Apr 2024
- First submitted
- 9 May 2018
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Secades-Villa R, Gonzalez-Roz A, Garcia-Perez A, Becona E. Psychological, pharmacological, and combined smoking cessation interventions for smokers with current depression: A systematic review and meta-analysis. PLoS One. 2017 Dec 5;12(12):e0188849. doi: 10.1371/journal.pone.0188849. eCollection 2017.
PubMed 29206852McKelvey K, Thrul J, Ramo D. Impact of quitting smoking and smoking cessation treatment on substance use outcomes: An updated and narrative review. Addict Behav. 2017 Feb;65:161-170. doi: 10.1016/j.addbeh.2016.10.012. Epub 2016 Oct 27.
PubMed 27816663Secades-Villa R, Vallejo-Seco G, Garcia-Rodriguez O, Lopez-Nunez C, Weidberg S, Gonzalez-Roz A. Contingency management for cigarette smokers with depressive symptoms. Exp Clin Psychopharmacol. 2015 Oct;23(5):351-60. doi: 10.1037/pha0000044. Epub 2015 Aug 17.
PubMed 26280589Weidberg S, Vallejo-Seco G, Gonzalez-Roz A, Garcia-Perez A, Secades-Villa R. In-treatment cigarette demand among treatment-seeking smokers with depressive symptoms. Addict Behav. 2018 Jul;82:35-43. doi: 10.1016/j.addbeh.2018.02.022. Epub 2018 Feb 16.
PubMed 29482033Cooney JL, Cooper S, Grant C, Sevarino K, Krishnan-Sarin S, Gutierrez IA, Cooney NL. A Randomized Trial of Contingency Management for Smoking Cessation During Intensive Outpatient Alcohol Treatment. J Subst Abuse Treat. 2017 Jan;72:89-96. doi: 10.1016/j.jsat.2016.07.002. Epub 2016 Jul 15.
PubMed 27542442
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Treatment for Substance Use Dependents
- ClinicalTrials.gov ID
- NCT03551704
- Acronym / sponsor ID
- MSSSI-2017-2017I036
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking, Substance addiction, Cocaine, Alcohol, Behavioral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with substance use disorders (SUDs). For this purpose, two smoking cessation treatments tailored for SUDs will be assessed. Participants will be assigned to one of the following treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation (CBT) + Episodic Future Thinking (EFT); 2) The same treatment alongside Contingency Management (CM) for shaping abstinence.
The main goals are:
- To analyze the feasibility (e.g., acceptability, compliance) of implementing the abovementioned protocol treatments to a community setting.
- To assess abstinence rates in each treatment condition at short and long-term follow-ups: post-treatment, one, two, three, six and twelve months after post-treatment.
- To assess the effects of smoking abstinence on other substance use.
- To analyze the moderating effect of individual variables over treatment outcomes: sociodemographic characteristics, drug demand, severity of nicotine dependence and SUD, severity of depressive symptomatology and impulsivity.
Detailed description
Cigarette smoking continues to have a startling adverse impact on public health, leading to more than 5 million premature deaths annually worldwide. Smoking rates are disproportionately high among the population suffering from substance use disorders (SUDs) (e.g., alcohol or cocaine). In this regard, smokers with comorbid SUD are more likely to smoke heavily and meet criteria for high nicotine dependence. As they experience more difficulty in quitting smoking than their non-SUDs counterparts, they present lower rates of abstinence.
In recent years there has been a great interest in developing effective strategies to promote abstinence in smokers with SUDs. In particular, a proliferation on CM treatments for smokers with SUDs has been recently produced. There is promising evidence for the positive effect of CM treatments upon both quitting smoking and both legal and illegal abuse drugs. On the other hand, CM has shown promising results in promoting both retention and nicotine abstinence among comorbid and non-comorbid smokers. Nevertheless, there is a lack of research exploring the effectiveness of CM on smokers with SUDs.
The primary aim of this clinical trial is to yield data on the effectiveness of CM for smoking cessation in smokers with SUDs. To address this issue, both CBT for smoking cessation plus EFT, and the same treatment alongside CM for shaping abstinence will be assessed. Participants will be randomly assigned to one of the following treatment conditions: 1) CBT+EFT; 2) CBT+EFT+ CM.
In view to assure adequate power for achieving statistical significance, investigators carried out a priori power analysis by using the G*Power 3.1. An estimated sample size of 120 participants would detect a medium effect size (Cohen's d = 0.3, with power (1-β) set at 0.97 and α = 05).
The primary analyses derived from this clinical trial will be conducted using Statistical Package for the Social Science (SPSS) version 24 for Windows. A set of descriptive and frequency analyses will be carried out with regard to participants' characteristics. Comparisons between treatment groups in both baseline characteristics and treatment outcomes will be conducted using a set of chi-square tests for categorical variables and t-tests (two-tailed) for continuous variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to each of the two treatment conditions in accordance with a computer-generated randomization list. The treatment conditions will be actively running in parallel.
| Arm | Type | Receives |
|---|---|---|
| CBT + EFT | Active comparator | Behavioral: CBT + EFTThe CBT treatment will be implemented in 8-week group-based sessions (maximum 4 patients). Sessions will be carried out once a week over an 8-week period, with quit date occurring at fifth session. Patients will be asked to gradually reduce their nicotine intake (i.e., 25% each week). CBT components include: psychoeducation, self-monitoring, physiological feedback, training in stimulus control and strategies for controlling negative discomfort, and relapse prevention strategies. As part of the EFT, participants will be asked to select future smoking-related events that would occur within the following time periods: 2 weeks, 1, and 6 months. They will be instructed to generate personal audio recordings that will be used to help them think about future decision-making choices. |
| CBT + EFT + CM | Experimental | Behavioral: CBT + EFT + CMThis intervention includes the abovementioned treatment components and a CM procedure reinforcing abstinence. This arm will consist on delivering CBT and EFT and providing patients incentives to promote and reinforce abstinence contingent on biochemical verification. The schedule will incorporate an increasing magnitude of reinforcement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being aged 18 or over.
- Having smoked 10 or more cigarettes/day within the last year.
- Meeting the diagnostic criteria for nicotine dependence according to the Diagnostic and Statistical Manual of Mental Disorders-5th ed. (American Psychiatric Association 2013).
- Undergoing outpatient cocaine or alcohol treatment.
Key exclusion criteria (3 listed)
- Not being able to attend the entire treatment.
- Being currently receiving other psychological/pharmacological treatment for smoking cessation.
- Being diagnosed with a current severe psychiatric disorder (i.e., schizophrenia,bipolar disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT + EFTThe CBT treatment will be implemented in 8-week group-based sessions (maximum 4 patients). Sessions will be carried out once a week over an 8-week period, with quit date occurring at fifth session. Patients will be asked to gradually reduce their nicotine intake (i.e., 25% each week). CBT components include: psychoeducation, self-monitoring, physiological feedback, training in stimulus control and strategies for controlling negative discomfort, and relapse prevention strategies. As part of the EFT, participants will be asked to select future smoking-related events that would occur within the following time periods: 2 weeks, 1, and 6 months. They will be instructed to generate personal audio recordings that will be used to help them think about future decision-making choices. | Behavioural | CBT + EFT |
| CBT + EFT + CMThis intervention includes the abovementioned treatment components and a CM procedure reinforcing abstinence. This arm will consist on delivering CBT and EFT and providing patients incentives to promote and reinforce abstinence contingent on abstinence. The schedule will incorporate an increasing magnitude of reinforcement. | Behavioural | CBT + EFT + CM |
Primary outcome
Changes in Smoking Abstinence
Time frame: End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up
Abstinence is defined as achieving a period of at least 24 hours of abstinence (end-of-treatment) or not smoking since the prior last 7 days. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
Changes in Continuous abstinence
Time frame: 1, 2, 3, 6 and 12 month follow-up since the treatment completion
Abstinence is defined as no smoking (not even a puff) since the participant´s quit day. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
6 secondary outcomes
Changes in Other Substance Abstinence
Time frame: End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up since the treatment completion
Changes in Drug demand
Time frame: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Changes in Health-Related Quality of Life
Time frame: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Changes in Depression
Time frame: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Changes in Impulsivity
Time frame: Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion
Cost Analysis
Time frame: End of the project when all participant´s data are collected. Data expected: three years after the study onset.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 29206852Secades-Villa R, Gonzalez-Roz A, Garcia-Perez A, Becona E. Psychological, pharmacological, and combined smoking cessation interventions for smokers with current depression: A systematic review and meta-analysis. PLoS One. 2017 Dec 5;12(12):e0188849. doi: 10.1371/journal.pone.0188849. eCollection 2017.
- Results publication: PubMed 27816663McKelvey K, Thrul J, Ramo D. Impact of quitting smoking and smoking cessation treatment on substance use outcomes: An updated and narrative review. Addict Behav. 2017 Feb;65:161-170. doi: 10.1016/j.addbeh.2016.10.012. Epub 2016 Oct 27.
- Results publication: PubMed 26280589Secades-Villa R, Vallejo-Seco G, Garcia-Rodriguez O, Lopez-Nunez C, Weidberg S, Gonzalez-Roz A. Contingency management for cigarette smokers with depressive symptoms. Exp Clin Psychopharmacol. 2015 Oct;23(5):351-60. doi: 10.1037/pha0000044. Epub 2015 Aug 17.
- Results publication: PubMed 29482033Weidberg S, Vallejo-Seco G, Gonzalez-Roz A, Garcia-Perez A, Secades-Villa R. In-treatment cigarette demand among treatment-seeking smokers with depressive symptoms. Addict Behav. 2018 Jul;82:35-43. doi: 10.1016/j.addbeh.2018.02.022. Epub 2018 Feb 16.
- Results publication: PubMed 27542442Cooney JL, Cooper S, Grant C, Sevarino K, Krishnan-Sarin S, Gutierrez IA, Cooney NL. A Randomized Trial of Contingency Management for Smoking Cessation During Intensive Outpatient Alcohol Treatment. J Subst Abuse Treat. 2017 Jan;72:89-96. doi: 10.1016/j.jsat.2016.07.002. Epub 2016 Jul 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Secades-Villa, PhD principal investigator
University of Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT + EFT and CBT + EFT + CM in people with Tobacco Use Disorder, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Smoking Abstinence (time frame: End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03551704, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.